September 6, 2007

Two diphtheria, tetanus, and pertussis vaccines with age-specific indications have undergone significant package redesign in order to reduce the likelihood of mix-ups. Vaccine safety and efficacy may be compromised if the incorrect product is administered. Read more to learn how reader reports contributed to package redesign.

New design for infusion product.

PharMEDium changed the cap used to seal the port on IV minibags containing admixtures compounded for the Baxter APII pain management pump. Erroneous connections that impede medication delivery are less likely to occur with the new design.

The National Patient Safety Agency in the United Kingdom issued a medication alert warning healthcare providers of the risk of confusion between conventional and liposomal formulations of amphotericin B. ISMP has re-issued recommendations to help providers avert these serious mix-ups.

Free FDA patient safety videos.

The FDA, in collaboration with ISMP, produces free medication safety videos that may be viewed and downloaded through the ISMP website. Visit www.ismp.org/Tools/fdavideos.asp to view titles and access the videos.

PDUFA IV.

Legislation before Congress, Prescription Drug User Fee Act IV (PDUFA IV), addresses best practices for naming, labeling, and packaging pharmaceuticals and biologic agents. PDUFA IV also includes provisions to ensure that standards are defined and followed. ISMP has long-championed this cause.

Special Announcements…

ISMP-USP workshops.ISMP and USP are offering workshops on collecting, analyzing, and prioritizing adverse drug event data. The full-day programs, Using Data Effectively to Manage the Risks to Medication Safety, will be held in Tampa, Chicago, Rockville, and Las Vegas, between September and December 2007.

September 20, 2007

FENTORA (fentanyl transmucosalbuccal tablets) use has been linked to serious adverse outcomes, including death, when prescribed for the management of acute pain in patients who are not opiate tolerant. Additionally, prescribers are cautioned that mcg-to-mcg conversions are not appropriate when patients who have been receiving other fentanyl products--including ACTIQ (fentanyl transmucosal lozenges)--are switched to buccal fentanyl tablets. Read the full article for additional measures to ensure safe use of these products.

Cardiac catheterization lab error.

Weak dose-checking processes and poor communication led to a medication error in which 25 mg of IV nitroglycerin was erroneously administered instead of heparin to a patient undergoing cardiac catheterization.

In 8 year period, reported adverse events increased nearly 3-fold.

An ISMP study published last week in the Archives of Internal Medicine showed that the number of serious adverse drug events reported to FDA increased 2.6 fold between 1998 and 2005. Other findings included a 2.7 fold increase in the number of fatal adverse drug events. Drugs most likely to be associated with fatal adverse drug events are identified.

Special Announcements…

ISMP-USP workshops

ISMP and USP are offering workshops on collecting, analyzing, and prioritizing adverse drug event data. The full-day programs, Using Data Effectively to Manage the Risks to Medication Safety, will be held in Tampa, Chicago, Rockville, and Las Vegas, between September and December 2007. For details, click here

New 2007-2008 ISMP Fellow.

Barbara Olson,RN-C, MS, has joined ISMP as the 2007-2008 ISMP Safe Medication Management Fellow. Ms. Olson has an extensive background in perinatal nursing, clinical performance improvement, and has practiced in a variety of healthcare settings. Ms. Olson will be working closely with ISMP staff and other patient safety organizations during the 12-month fellowship, which is funded through an unrestricted grant from Cardinal Health.

Med-E.R.R.S marks 10 years of service.

Our subsidiary, Med-E.R.R.S, has provided packaging design consultation to the pharmaceutical industry for 10 years! As one of its 10-year anniversary activities, Med-E.R.R.S will sponsor a teleconference for the pharmaceutical industry, Spotlight on Medication Safety: Designing Safe Packaging and Labels, on Wednesday, November 14, 2007 from 1:30-3:00 p.m., ET. For details, visit: www.med-errs.com/teleconferences/.